Vendor: RAPS
Certifications: RAC Regulatory Affairs Certification
Exam Name: Regulatory Affairs Certification (RAC) Global Scope
Exam Code: RAC-GS
Total Questions: 100 Q&As
Last Updated: Mar 20, 2024
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VCE
RAPS RAC-GS Last Month Results
RAC-GS Q&A's Detail
Exam Code: | RAC-GS |
Total Questions: | 100 |
CertBus Has the Latest RAC-GS Exam Dumps in Both PDF and VCE Format
RAC-GS Online Practice Questions and Answers
Which term does NOT describe the same concept as the others?
A. Biosimilars
B. Follow-on protein products
C. Monoclonal antibody
D. Subsequent entry biologics
In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?
A. Potential clinical sites for the Phase III clinical trial
B. Regulatory requirements for labeling and packaging
C. Capacity of the manufacturing facilities to fully produce the new product
D. Previous actions taken by regulatory authorities on similar products
At a recent scientific meeting,Company Y had two booths:
At one booth,Company Y provided brochures on a completed Phase II study.
In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
A. Acknowledge receipt of the letter in a written response but do nothing further.
B. Inform the legal department of the letter and discuss how to respond.
C. Inform Company X that it has no right to send such a letter and do nothing further.
D. Inform the local regulatory authority of the letter and discuss how to respond.
The regulatory authority in Country X issued a request for a mandatory product recall in Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in Country Y?
A. Draft a formal letter to customers in Country Y about this recall.
B. Initiate a mandatory recall of the product in Country Y.
C. Review alt distribution records and complaints reported in Country Y.
D. Prepare the legal team in Country Y for possible litigations.
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
A. Instructions for use
B. Risk analysis
C. Product literature
D. Essential principles
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